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REGULATORY AND QUALITY

Software Compliance

Donawa Lifescience Consulting (DLC) can provide specialized computer system validation and compliance services, including evaluation of existing documentation and advice on any actions that may be needed to comply with European and US requirements.

Many medical devices contain software components or parts which monitor or control the system, such as

  • firmware or other software-based control
  • stand-alone software applications
  • device-related software for installation in other computers
  • dedicated hardware/software for medical devices
  • accessories to medical devices

The medical device then becomes a ‘software device’ and special documentation is required to achieve compliance with current regulations, including CE marking and preparation of US 510(k) or PMA submissions. DLC specialists in software validation can help preparation of this documentation, including the ‘level of concern’ and the applicable documents for submission, including:

  • software description
  • hazard analysis & risk assessment
  • software requirements
  • architecture design
  • software design
  • traceability
  • development environment
  • verification & validation
  • management of anomalies

IEC/ISO 62304 is the international standard for the medical device software life-cycle process model. This standard covers software development & maintenance, risk management according to ISO 14971, partitioning and safety classification of software items, and software process management.

Please  contact us, and we will be pleased to help review or prepare software documentation to meet standards and guidance documents applicable to both European and US requirements.

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